Tralokinumab Shows Strong Real-World Efficacy in Atopic Dermatitis for Patients With Skin of Color: April Armstrong, MD, MPH

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At the American Academy of Dermatology (AAD) 2026 Annual Meeting, April Armstrong, MD, MPH, professor and chief, UCLA Department of Dermatology, presented findings from the TRACE study (NCT04587453), in which 80% of patients with skin of color with atopic dermatitis (AD) achieved clinical response at 12 months with tralokinumab (Adbry; LEO Pharma).

Real-world evidence is increasingly critical in guiding treatment decisions for AD, particularly in populations that have historically been underrepresented in clinical trials. The TRACE study provides important new data on the performance of tralokinumab in patients with skin of color, addressing a meaningful gap in the evidence base.

TRACE was a global, real‑world, observational study that enrolled more than 800 patients with AD initiating tralokinumab. Notably, approximately 16% of participants were patients with skin of color, defined as Fitzpatrick skin types 4 to 6. This subgroup has often been overlooked in traditional clinical trials, despite well-recognized differences in disease presentation and barriers to care.

Patients were followed for 12 months after starting tralokinumab. Among those with skin of color, investigators observed an early onset of efficacy, with improvements emerging soon after treatment initiation. By the end of the 12‑month follow-up, 80% of patients in this subgroup were classified as responders. A response was defined as achieving clear or almost clear skin or attaining an Eczema Area and Severity Index score below 7.

These results are particularly meaningful because patients with skin of color are often more difficult to treat, for reasons that span phenotypic differences, diagnostic challenges, and structural barriers to access. In the study, tralokinumab’s efficacy in the skin of color subgroup was comparable with that observed in the overall study population, suggesting that the biologic can offer consistent benefit across diverse patient groups.

Beyond traditional clinical end points such as erythema reduction, the study also evaluated parameters highly relevant to patients with richly pigmented skin, including hyperpigmentation, as well as patient-reported outcomes. Participants reported improvements in itch, quality of life, and sleep—domains that reflect the broader burden of AD and are central to patient-centered care.

Taken together, the TRACE findings reinforce the importance of systematically studying underrepresented populations in both clinical trials and real-world settings. These data support the use of tralokinumab as an effective option for patients with skin of color living with AD.